Clinical Study to Investigate the Efficacy and the Safety... | NCT01438957

NCT01438957

Status Module

Sponsor/Collaborators Module

Name	Class
Maruishi Pharmaceutical	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose	Drug: Placebo
Dexmedetomidine 0.067 mcg/kg	Experimental	Dexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose	Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.25 mcg/kg	Experimental	Dexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose	Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 0.5 mcg/kg	Experimental	Dexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose	Drug: Dexmedetomidine hydrochloride
Dexmedetomidine 1.0 mcg/kg	Experimental	Dexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose	Drug: Dexmedetomidine hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine hydrochloride	Drug	Dexmedetomidine 0.2 to 0.7 mcg/kg/hr	Dexmedetomidine 0.067 mcg/kg Dexmedetomidine 0.25 mcg/kg Dexmedetomidine 0.5 mcg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.		Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.

Secondary Outcomes

Measure	Description	Time Frame
Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration		15 minutes after the start of study drug, if the OAA/S score is 5.
Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient has signed and dated the Informed Consent after the study had been fully explained.
Patient is male or female, at least 20 years of age when the Informed Consent is obtained.
American Society for Anesthesiologists (ASA) I to III Class.
Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
Patient undergoing a surgery requiring epidural or spinal anesthesia

Exclusion Criteria:

Patient who underwent general anesthesia within 7 days, or who received other study drugs within 30 days from the date of consent.
Patient with <92% SpO2, at the physical examination prior to the study drug administration, or ventilatory failure which requires intubation or Laryngeal Mask.
Patient with central nervous system pathology which may lead to increased intracranial pressure, uncontrolled seizures, psychiatric disorder which may be confused with the response to sedation treatment.
Patient who require general anesthesia.
Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
Patient diagnosed with unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
Patient whose heart rate is <60 bpm, systolic blood pressure is <90 mmHg by the physical examination prior to the study drug administration.
Patient has third degree heart block, unless the patient has a pacemaker or transverse pacing wires are in place.
Patient who has experienced an increase in alanine transaminase (ALT) and / or aspartate aminotransferase (AST) more than double the upper normal limit within 2 months of the date of consent, or who has a history of liver insufficiency.
Pregnant or lactating woman.
In the Investigator's or subinvestigator's opinion, the patient has any symptom or condition which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nagoya University Hospital		Nagoya	Aichi-ken		Japan
Asahikawa Medical University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35221757	Derived	Inagaki Y, Yamakage M, Sakamoto A, Okayama A, Oya N, Hiraoka T, Morita K. The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study. Yonago Acta Med. 2022 Jan 4;65(1):14-25. doi: 10.33160/yam.2022.02.002. eCollection 2022 Feb.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
FG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Dexmedetomidine 1.0 mcg/kg

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Arm/Group Information

ID	Title	Description
BG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
BG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
BG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
BG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
BG004	Dexmedetomidine 1.0 mcg/kg	6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00069.0(51 to 86) BG00160.7(33 to 85) BG00263.8(27 to 86) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Number

95% Confidence Interval

Percentage of participants

Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg	6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Units	Counts
Participants	OG00022 OG00123 OG00224 OG003

Title

Denominators

Categories

Title	Measurements
	OG00022.7(7.8 to 45.4) OG00113.0(2.8 to 33.6) OG00245.8(25.6 to 67.2) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG004	The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order	Mantel Haenszel	Stratified by the anesthesia type	<0.001						2-Sided	5							Superiority

Secondary

Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Number of dosing

15 minutes after the start of study drug, if the OAA/S score is 5.

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg

Secondary

Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

mg/kg

15 minutes after the start of study drug, if the OAA/S score is 5.

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg

Secondary

Time to First Rescue Administration of Propofol

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Median

95% Confidence Interval

minutes

During the study drug infusion period (≥15 minutes [Approximate])

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg	6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Number

95% Confidence Interval

Percentage of participants

After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004

Secondary

Number of Fentanyl Dosing Required During the Study Drug Administration.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Number of dosing

During the study drug administration

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg	6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Dosage of Fentanyl Dosing Required During the Study Drug Administration.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

mcg/kg

During the study drug administration

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg	6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Percentage of time

Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg

Secondary

Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Percentage of time

Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg

Secondary

Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Median

95% Confidence Interval

Minutes

Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8.

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG004	Dexmedetomidine 1.0 mcg/kg

Secondary

Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)

VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)

VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)

VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)

VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure")

Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration (as much as possible)

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery")

Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration (as much as possible)

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time")

Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration (as much as possible)

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery")

Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration (as much as possible)

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery")

Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration (as much as possible)

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Secondary

Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")

Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.

Full Analysis Set<FAS>: FAS is defined as all patients who were administered with the study drugs.

Posted

Mean

Standard Deviation

Scores on a scale

Within 24 hours after completion of the study drug administration (as much as possible)

ID	Title	Description
OG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
OG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
OG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose	22	0	22	19	22
EG001	Dexmedetomidine 0.067 mcg/kg	0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose	23	1	23	21	23
EG002	Dexmedetomidine 0.25 mcg/kg	1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose	24	0	24	24	24
EG003	Dexmedetomidine 0.5 mcg/kg	3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose	25	0	25	22	25
EG004	Dexmedetomidine 1.0 mcg/kg	6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose	25	0	25	25	25

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Sepsis	Infections and infestations		Systematic Assessment		EG0000 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG0030 affected25 at risk EG0040 affected25 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG0030 affected25 at risk EG0040 affected25 at risk
Restlessness	Psychiatric disorders	Systematic Assessment	EG0000 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG003
Sensory disturbance	Nervous system disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0021 affected24 at risk EG003
Headaches	Nervous system disorders	Systematic Assessment	EG0002 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG003
Extrasystoles	Cardiac disorders	Systematic Assessment	EG0000 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG003
Bradycardia	Cardiac disorders	Systematic Assessment	EG0008 affected22 at risk EG00111 affected23 at risk EG0029 affected24 at risk EG003
Tachycardia	Cardiac disorders	Systematic Assessment	EG0002 affected22 at risk EG0013 affected23 at risk EG0020 affected24 at risk EG003
Vasculitides	Vascular disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0005 affected22 at risk EG0012 affected23 at risk EG0022 affected24 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0005 affected22 at risk EG00112 affected23 at risk EG00211 affected24 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Respiratory depression	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00012 affected22 at risk EG00111 affected23 at risk EG00212 affected24 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected22 at risk EG0013 affected23 at risk EG0022 affected24 at risk EG003
Apnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected22 at risk EG0010 affected23 at risk EG0021 affected24 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected22 at risk EG0010 affected23 at risk EG0021 affected24 at risk EG003
Glossoptosis	Gastrointestinal disorders	Systematic Assessment	EG0003 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Faecal incontinence	Gastrointestinal disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0021 affected24 at risk EG003
Anal fissure	Gastrointestinal disorders	Systematic Assessment	EG0000 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 affected22 at risk EG0010 affected23 at risk EG0021 affected24 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0021 affected24 at risk EG003
Erythemas	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG003
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG003
Hydronephrosis	Renal and urinary disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Urethral pain	Renal and urinary disorders	Systematic Assessment	EG0000 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG003
Bladder irritation	Renal and urinary disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0022 affected24 at risk EG003
Bladder spasm	Renal and urinary disorders	Systematic Assessment	EG0000 affected22 at risk EG0011 affected23 at risk EG0020 affected24 at risk EG003
Chills	General disorders	Systematic Assessment	EG0001 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Thirst	General disorders	Systematic Assessment	EG0000 affected22 at risk EG0011 affected23 at risk EG0021 affected24 at risk EG003
Puncture site pain	General disorders	Systematic Assessment	EG0002 affected22 at risk EG0010 affected23 at risk EG0021 affected24 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0001 affected22 at risk EG0011 affected23 at risk EG0021 affected24 at risk EG003
Pain	General disorders	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Oxygen saturation decreased	Investigations	Systematic Assessment	EG0001 affected22 at risk EG0010 affected23 at risk EG0020 affected24 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected22 at risk EG0010 affected23 at risk EG0021 affected24 at risk EG003

ID	Term
D020927	Dexmedetomidine

OG00480.0(59.3 to 93.2)

6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose

EG0040 affected25 at risk

EG0041 affected25 at risk

EG0040 affected25 at risk

EG00411 affected25 at risk

EG0040 affected25 at risk

EG0041 affected25 at risk

EG0048 affected25 at risk

EG00410 affected25 at risk

EG0041 affected25 at risk

EG00411 affected25 at risk

EG0043 affected25 at risk

EG0041 affected25 at risk

EG0040 affected25 at risk

EG0042 affected25 at risk

EG0040 affected25 at risk

EG0041 affected25 at risk

EG0040 affected25 at risk

EG0042 affected25 at risk

EG0040 affected25 at risk

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds